In order to correctly diagnose or confirm the presence of disease in a patient, a physician typically must excise a sample of diseased tissue and have that tissue examined on a microscopic level by a pathologist. Using a plurality of analysis techniques and laboratory instruments, the pathologist will be able to analyze the diseased tissue to identify any structural (or other) changes in cell tissues and organs. In most cases, the pathologist may be able to 1) identify the type of disease, 2) establish a prognosis on the likely progression of the disease, and 3) make a determination as to what therapy might be most effective in curing or treating the disease. As with most diseases, one important element to a successful treatment or cure is the ability of the physician to rapidly and effectively treat the patient before the disease progresses to an incurable state. This requires that the pathologist have the ability to rapidly analyze the tissue sample, diagnose the condition and disseminate this information to the patient's physician, all the while maintaining accuracy and reliability.
Laboratory Information Systems (LIS) are known for management of patient and laboratory information. Such systems typically consist of a server or host computer, a data base and data base management system, and application software for receiving and processing patient information. Known LIS may be “web-enabled” to facilitate access of the system and information over the Internet.
Unfortunately, however, current Laboratory Information Systems tend to lack the ability to manage workflow with certain laboratory instrumentation, such as, for example, an advanced staining instrument. This management includes basic connectivity, data exchange capability and business rules implemented to optimize workflow, costs and efficiencies. As such, there exist several deficiencies in how these instruments are utilized in the laboratory. A significant amount of time and energy is expended replicating tedious functions, such as data entry, labeling and manual entry for report generation. This replication increases the amount of time it takes to process samples by creating a significant bottleneck in laboratory work flow. The tedious nature of these tasks can substantially increase errors and can affect the accuracy of the diagnostic process. The resulting increase in test completion time may allow a localized disease to progress into systemic proportions, such as a localized tumor metastasizing, having a devastating effect on patient prognosis and/or treatment options and results.
One example of how a bottleneck in laboratory work flow may occur is illustrated in FIG. 1. Typically, a pathologist receives a sample for testing, and orders tests 10. Upon receipt of a tissue sample, accessioning and test order information is entered into the LIS by a laboratory technician 12. However, because the LIS is not connected to the laboratory instruments, the accessioning and test order information that was just entered into the LIS needs to be sent to the test laboratory 14 and re-entered into each laboratory instrument that will be used for testing in order to create slide labels 16. This could take a significant amount of time depending on the number of samples and the extent of testing being performed on the samples. Additionally, each time this data entry function is replicated, the possibility of error in the information transfer increases, reducing the accuracy and reliability of the testing procedure.
Another example of how a bottleneck in laboratory work flow may occur is described as illustrated in FIG. 2 and involves the generation of a status report. Again, the pathologist receives the test sample and orders tests 18. Accessioning and test ordering information is entered into the LIS 20, and then such information must be sent to the test lab 22. Then accessioning and test order information has to be entered into a laboratory instrument 24, such as an advanced staining instrument, and a slide label is generated and the laboratory instrument will begin performing the ordered test. In some cases, the pathologist, lab manager and technician may be keenly interested in the progress of the test and thus may desire to monitor the status of the test. Unfortunately however, the lack of data communications between the LIS and the laboratory instruments prevents test status monitoring by precluding the automatic generation of a test status report. As such, in order to check the status of the test the testing must be interrupted 26 and a test status report must be manually generated.
In addition to this lack of connectivity creating a bottleneck in laboratory work flow, the diagnostic capability of the laboratory is also adversely affected due to the reality that current laboratory set-ups do not have the ability to perform many new and advanced features which may substantially increase the timeliness, reliability and accuracy of new and existing tests.
One way to maximize the timeliness, reliability and accuracy of the sample analysis, condition diagnosis and dissemination of information would be to establish a communication connection between the LIS and the laboratory instrumentation. The extent to which the work flow bottleneck or the performance efficiency would be improved thus would be dependent upon the type of connectivity (unidirectional or bidirectional) established between the LIS and the laboratory instrumentation. For example, a unidirectional, or one-way, connection between the LIS and the laboratory instrumentation would allow for test result information to flow, in one direction, between the laboratory instrument and the LIS, thus eliminating duplicate data entry. Similarly, a bidirectional, or two-way, connection between the LIS and the medical laboratory instrumentation would enable new advanced features to be included, such as order entry and tracking, status updates, sample tracking, quality control, College of American Pathologists (CAP) compliance, inventory management and maintenance, all of which would increase performance time, reliability and accuracy.
Unfortunately however, a suitable system management structure does not exist that would allow for effective control between the LIS and automated laboratory instrumentation, such as staining instrumentation, such that the timeliness of the test performance, data analysis, disease diagnosis and information dissemination process is substantially optimized. Additionally, known systems for interconnecting laboratory instrumentation and information systems do not effectively and automatically identify, prioritize and stage specimens to optimize the throughput and utilization of the automatic staining systems. Nor do known systems have the capability to automate the identification, labeling and tracking of specimens and results through the clinical pathology process. Furthermore, known systems are not specifically capable of optimizing the storage, use, and management of the reagents between staining systems necessary for performing the multitude of staining procedures for disease diagnosis.